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Testing the Feasibility of the Individualized Positive Psychosocial Intervention (IPPI)

Testing the Feasibility of the Individualized Positive Psychosocial Intervention (IPPI)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05980299
Acronym
IPPI
Enrollment
200
Registered
2023-08-07
Start date
2023-07-10
Completion date
2025-03-01
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Dementia, Depression

Keywords

dementia, depressive symptoms, psychosocial intervention, feasibility, emotion

Brief summary

The goal of this clinical trial is to test the feasibility of the Individualized Positive Psychosocial Interaction (IPPI) with 108 nursing home residents living with dementia and distress or depressive symptoms. The main questions it aims to answer are: •is it feasible to deliver the IPPI and track impact through data collected in the electronic medical records. Care partners will engage eligible residents in 2 brief preference-based IPPIs per week over the course of 6 months.

Detailed description

Specific Aims. Psychological and behavioral symptoms of distress (BPSD) expressed by people living with dementia (PLWD) are challenging to respond to in nursing home (NH) care. Experienced by 78% of PLWD, BPSD can include wandering, persistent vocalizations, and resistance or refusal of care.1 In addition, 30% of NH residents experience depressive symptoms2 and among those with depressive symptoms, 47% also have dementia.3 Together, these conditions will be referred to as distress throughout this proposal. Without appropriate guidance or training, care partners (e.g., Certified Nursing Assistants) struggle to prevent or positively remediate distress experienced by PLWD. The Individualized Positive Psychosocial Intervention (IPPI) is an evidence-based program designed to support care partners in engaging PLWD with brief (i.e.,10 minute) one-to-one preference-based activities. IPPI is designed to enhance well-being and reduce negative emotional and behavioral responses using non-pharmacological approaches that align care with residents' preferences recorded in Section F of the MDS (e.g., choose what clothes to wear). Specifically, in our IPPI randomized controlled trial (RCT) effectiveness trial,4 NH residents receiving the IPPI program delivered by care partners experienced more pleasure, alertness, engagement, and positive verbal behavior compared with the usual care group. Our goal with this proposal is to partner with United Church Homes (UCH), a 106-year-old nonprofit national senior living provider to conduct a full implementation feasibility pilot of the IPPI program with long-stay residents in 9 of their NHs. Our objective is to conduct a pilot study to evaluate 1) the ability of staff to identify residents who are optimal for the IPPI, 2) implementation of IPPI, and 3) the impact on pragmatic clinical outcome measures (BPSD and depressive symptoms). Staff champions will be identified by the stakeholder team in each NH (e.g., Director of Nursing, Activity Professional) and trained to identify residents optimal for the IPPI (i.e., experiencing cognitive impairment (Minimum Data Set (MDS) Brief Inventory for Mental Status (BIMS) score 0-12) as well as documentation (MDS Section E or D) of distress within the past 3-months. Distress is indicated by a 1 or higher on any of the 5 behavior items from MDS Section E (i.e., physical, verbal, other behavior, rejection of care, wandering) and/or a score of 1 or higher on one of 5 MDS section D items (i.e., anhedonia, sad mood, poor self-esteem, poor appetite, restlessness). Care partners of identified residents will be invited to be trained to deliver IPPI. The investigators anticipate that each NH will initiate engagement with 4-5 residents per month for each of 3 consecutive months (12-15 residents per NH) in addition to 3-4 care partners who will deliver the IPPI. Resident initiation in the program will occur on a rolling basis (i.e., initiating intervention activities for a given resident when he/she is due for a routine quarterly care plan review). Each selected resident will then receive 2 IPPI sessions per week for 6 months. The project seeks to achieve the following specific aims: Aim 1. To conduct a pilot embedded Pragmatic Clinical Trial (ePCT) to evaluate and establish the feasibility of implementing the IPPI program in 9 NHs among 108-135 residents. Quantitative implementation endpoints indicating success include (a) that staff in each community will be able to identify and engage 12-15 residents experiencing both dementia (e.g., BIMS 0-12) and distress (either BPSD or depressive symptoms) within the past 2 weeks, measured by a count of participants; (b) that all the implementation team members (champions and care partners) can complete the online training within the first two months of initiating implementation, as indicated by the learning management system; (c) that the implementation team will be able to (i) review existing data from Section F of the MDS for all selected residents; (ii) identify a match between a resident's important preferences and 1-2 IPPI protocols; (iii) identify a targeted expression of distress as measured by documentation in the electronic medical record; and (d) that staff can conduct at least 2 ten-minute sessions per week, per targeted resident with fidelity over the course of 6 months as measured in the electronic medial record (EMR). Qualitative data to evaluate implementation will be ascertained from semi-structured interviews with implementation team members in each community to assess acceptability, feasibility, and appropriateness as well as facilitators and barriers to fidelity of the IPPI sessions. Aim 2. To establish the feasibility of tracking intervention impact on a primary clinical outcome of a targeted behavior (identified by staff) through the MDS Section E (E0200A, B or C; or E0800) or MDS Section D (Patient Health Questionnaire (PHQ-9) items of anhedonia, sad mood, poor self-esteem, poor appetite, or restlessness). The primary outcome measure will consist of a single variable indicating improvement, no change, or worsening of a staff-targeted behavior of distress of each resident receiving the intervention, tracked pre- and post-IPPI intervention using routinely collected data in the EMR. Secondary staff outcomes will include knowledge of emotion-focused communication and staff reported self-efficacy in applying the communication skills. IMPACT: The IPPI program teaches care partners strategies to better identify and manage their own feelings and those of PLWD through our emotion-focused communication course. In addition, the program provides highly structured and feasible protocols to guide short but impactful interactions with PLWD designed to prevent and remediate distress (i.e., BPSD and symptoms of depression). Findings from this pilot study will guide the implementation, approach, and power needed for a full-scale Stage IV effectiveness ePCT study.

Interventions

BEHAVIORALIndividualized Positive Psychosocial Interaction

The intervention involves a brief positive interaction around a preferred activity or personal care routine.

Sponsors

United Church Homes
CollaboratorUNKNOWN
Penn State University
CollaboratorOTHER
Virginia Polytechnic Institute and State University
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Miami University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No

Inclusion criteria

Eligibility for Individualized Positive Psychosocial Interaction (IPPI) 1. Be a long-term resident in a nursing home 2. Have a score of 0-12 on the Brief Inventory for Mental Status (BIMS) 3. Either (could be both) on their most recent Minimum Data Set (MDS) 3.0 assessment A score of 1 or higher on any of the 5 behavior items from MDS Section E (i.e., physical, verbal, other behavior, rejection of care, wandering) A score of 1 or higher on one of 5 MDS section D items (i.e., anhedonia, sad mood, poor self-esteem, poor appetite, restlessness)

Exclusion criteria

Nursing home residents who are expected to live in the community for less than 6 months. \-

Design outcomes

Primary

MeasureTime frameDescription
Change in Physical Behavioral Symptoms Directed Toward Others6 MonthsThe investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.
Change in Verbal Behavior Symptoms Directed Towards Others6 MonthsThe investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.
Change in Other Behavioral Symptoms Not Directed Towards Others6 MonthsThe investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.
Change in Rejection of Care6 MonthsThe investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.
Change in Wandering6 MonthsThe investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.
Change in Little Interest or Pleasure in Doing Things6 MonthsThe investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress: Minimum Data Set (MDS) Section E (E0200A, B or C; or E0800) or MDS Section D (Patient Health Questionnaire (PHQ-9)
Change in Feeling Down, Depressed or Hopeless6 MonthsThe investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.

Countries

United States

Participant flow

Participants by arm

ArmCount
experimental
The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.
130
Staff Care partner
staff care partners delivering the IPPI
70
Total200

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath280
Overall StudyDischarged from Nursing Home90
Overall StudyLost to Follow-up010

Baseline characteristics

CharacteristicexperimentalTotalStaff Care partner
Age, Continuous
Resident
84.44 years
STANDARD_DEVIATION 8.21
84.44 years
STANDARD_DEVIATION 8.21
Age, Continuous
Staff Care Partner
40.35 years
STANDARD_DEVIATION 13.94
40.35 years
STANDARD_DEVIATION 13.94
Cognition4.68 units on a scale
STANDARD_DEVIATION 3.64
4.68 units on a scale
STANDARD_DEVIATION 3.64
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants6 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
117 Participants181 Participants64 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
12 Participants13 Participants1 Participants
Length of Stay16.79 Months
STANDARD_DEVIATION 22.18
16.79 Months
STANDARD_DEVIATION 22.18
Marital Status
Divorced
19 Participants19 Participants0 Participants
Marital Status
Married
31 Participants31 Participants0 Participants
Marital Status
Missing
1 Participants71 Participants70 Participants
Marital Status
Never Married
9 Participants9 Participants0 Participants
Marital Status
Widowed
70 Participants70 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants4 Participants4 Participants
Race (NIH/OMB)
More than one race
2 Participants4 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants13 Participants2 Participants
Race (NIH/OMB)
White
117 Participants178 Participants61 Participants
Sex: Female, Male
Female
96 Participants159 Participants63 Participants
Sex: Female, Male
Male
34 Participants41 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
28 / 1300 / 0
other
Total, other adverse events
0 / 1300 / 0
serious
Total, serious adverse events
28 / 1300 / 0

Outcome results

Primary

Change in Feeling Down, Depressed or Hopeless

The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.

Time frame: 6 Months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
experimentalChange in Feeling Down, Depressed or Hopelesssymptoms improved20 Participants
experimentalChange in Feeling Down, Depressed or Hopelesssymptoms worsened1 Participants
experimentalChange in Feeling Down, Depressed or HopelessSymptoms stayed stable2 Participants
Primary

Change in Little Interest or Pleasure in Doing Things

The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress: Minimum Data Set (MDS) Section E (E0200A, B or C; or E0800) or MDS Section D (Patient Health Questionnaire (PHQ-9)

Time frame: 6 Months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
experimentalChange in Little Interest or Pleasure in Doing ThingsSymptoms stayed stable3 Participants
experimentalChange in Little Interest or Pleasure in Doing Thingssymptoms improved15 Participants
experimentalChange in Little Interest or Pleasure in Doing Thingssymptoms worsened0 Participants
Primary

Change in Other Behavioral Symptoms Not Directed Towards Others

The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.

Time frame: 6 Months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
experimentalChange in Other Behavioral Symptoms Not Directed Towards OthersSymptoms stayed stable0 Participants
experimentalChange in Other Behavioral Symptoms Not Directed Towards Otherssymptoms improved18 Participants
experimentalChange in Other Behavioral Symptoms Not Directed Towards Otherssymptoms worsened0 Participants
Primary

Change in Physical Behavioral Symptoms Directed Toward Others

The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.

Time frame: 6 Months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
experimentalChange in Physical Behavioral Symptoms Directed Toward OthersSymptoms stayed stable4 Participants
experimentalChange in Physical Behavioral Symptoms Directed Toward Otherssymptoms improved13 Participants
experimentalChange in Physical Behavioral Symptoms Directed Toward Otherssymptoms worsened1 Participants
Primary

Change in Rejection of Care

The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.

Time frame: 6 Months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
experimentalChange in Rejection of CareSymptoms stayed stable5 Participants
experimentalChange in Rejection of Caresymptoms improved8 Participants
experimentalChange in Rejection of Caresymptoms worsened0 Participants
Primary

Change in Verbal Behavior Symptoms Directed Towards Others

The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.

Time frame: 6 Months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
experimentalChange in Verbal Behavior Symptoms Directed Towards Otherssymptoms worsened3 Participants
experimentalChange in Verbal Behavior Symptoms Directed Towards OthersSymptoms stayed stable5 Participants
experimentalChange in Verbal Behavior Symptoms Directed Towards Otherssymptoms improved12 Participants
Primary

Change in Wandering

The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.

Time frame: 6 Months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
experimentalChange in WanderingSymptoms stayed stable3 Participants
experimentalChange in Wanderingsymptoms improved8 Participants
experimentalChange in Wanderingsymptoms worsened1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026